Top 10 Innovations for 2013
#8 Modular Device for Treating Complex Aneurysms
Aortic aneurysms pose a serious medical problem and when they rupture, the
results are catastrophic and deadly.
Aneurysm comes from the Greek word "aneurysma," meaning, "a widening." The
aorta is the largest artery in the body and is the primary artery that carries blood
from the heart and lungs to the head and rest of the body. Generally, about an inch
in diameter, the aorta is shaped like a candy cane, rises out of the heart, and then
rounds down towards the abdomen. Over the course of a lifetime, it transports
200 million liters of blood and has to withstand the pressure of three billion or so
When someone has an aneurysm, there is a weak balloon-like bulge in the wall
of the aorta that causes the diameter to sometimes double in size over a period
of months or years. Abdominal aortic aneurysms, the most common, occur in the
section of the aorta that passes through the abdomen. Thoracic aortic aneurysms
occur in the portion of the aorta that passes through the chest. Aneurysms are
irreversible and the risk is that, as the aneurysm grows larger over time, it will
rupture, triggering massive internal bleeding, shock, and loss of consciousness.
Death is imminent in more than half of the cases, even for those who are able to
have emergency surgery. Aortic aneurysms are the 13th leading cause of death in
the United States, with over 15,000 fatalities annually. Most of these deaths could
have been avoided with proper monitoring and treatment.
Aneurysm treatment depends upon the size and location of the aneurysm and
the patient's overall health. If the aneurysm is large (5.5 to 6 cm in diameter),
enlarging rapidly, or leaking, then minimally invasive endovascular repair is the
preferred treatment. This entails special tests to visualize the aneurysm followed by
selection of a stent graft to fit the body.
During the surgical procedure, a catheter is inserted through the femoral artery in the leg and snaked up to the aneurysm, where it is positioned to release the stent graft within the aorta. The underlying metallic stent portion of the fabric graft immediately expands and holds it in place within the aorta,
reducing pressure on the aorta. Blood flows through the graft to arteries that go to the legs and, over time, the
aneurysm eventually shrinks.
Unfortunately, as many as 20 to 40% of people with aortic aneurysms have anatomies that are not suitable
for the grafts that are currently marketed, nor are they candidates for the more demanding open surgical repair
However, thanks to a new innovative fenestrated stent graft system, surgeons can now treat patients with these
complex aneurysms without having to take detailed measurements and then wait for weeks, sometimes months,
for the customized endografts to be delivered.
The FDA recently approved a multi-center trial of the modular stent device for aneurysms that come close to the
renal artery. The device incorporates individual branches to both renal arteries and the superior mesenteric artery.
Taken "off-the-shelf" by a surgeon, it can be used for both elective and urgent cases involving the renal arteries.
The new modular stent graft system represents a giant leap forward from prior aortic aneurysm technologies. Not
only does it offer a significant reduction in morbidity and ICU stay, but more importantly, it allows an application
of life-saving technology to high-risk patients who never could have been treated for their aneurysms.